ARCHITECT Anti-HCV, Alinity i Anti-HCV

FDA Premarket Approval P050042 S044

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Modifications to the sourcing and testing of materials used in the manufacture of an internal reference panel, which is used for quality control evaluation during in-process reagent manufacturing.

DeviceARCHITECT Anti-HCV, Alinity i Anti-HCV
Generic NameAssay, Enzyme Linked Immunosorbent, Hepatitis C Virus
ApplicantABBOTT LABORATORIES INC
Date Received2020-07-31
Decision Date2020-08-28
PMAP050042
SupplementS044
Product CodeMZO 
Advisory CommitteeMicrobiology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address ABBOTT LABORATORIES INC 100 Abbott Park Road ap5n-2, Dept 09vb abbott Park, IL 60064

Supplemental Filings

Supplement NumberDateSupplement Type
P050042Original Filing
S044 2020-07-31 30-day Notice
S043 2020-04-08 30-day Notice
S042
S041
S040
S039 2019-07-18 30-day Notice
S038 2018-12-28 30-day Notice
S037 2018-10-12 30-day Notice
S036 2018-10-10 30-day Notice
S035 2018-09-21 30-day Notice
S034
S033 2016-02-29 30-day Notice
S032 2015-07-16 30-day Notice
S031 2014-11-13 30-day Notice
S030 2014-09-19 30-day Notice
S029 2014-04-01 30-day Notice
S028 2013-10-30 30-day Notice
S027 2013-10-28 30-day Notice
S026 2013-10-18 30-day Notice
S025 2013-08-05 30-day Notice
S024 2013-04-23 30-day Notice
S023 2013-02-15 30-day Notice
S022 2013-02-11 30-day Notice
S021 2012-11-19 30-day Notice
S020 2012-11-15 30-day Notice
S019 2012-11-13 30-day Notice
S018 2012-08-03 30-day Notice
S017 2012-07-05 30-day Notice
S016 2012-03-15 30-day Notice
S015 2011-11-23 Special (immediate Track)
S014 2011-10-28 30-day Notice
S013 2011-05-25 30-day Notice
S012 2011-05-04 Normal 180 Day Track No User Fee
S011 2011-04-18 30-day Notice
S010 2011-02-17 Normal 180 Day Track No User Fee
S009 2011-01-19 30-day Notice
S008 2010-12-22 Special (immediate Track)
S007 2010-11-01 Normal 180 Day Track No User Fee
S006 2010-08-02 Normal 180 Day Track No User Fee
S005 2009-01-28 Normal 180 Day Track
S004 2008-12-23 30-day Notice
S003 2007-10-29 Real-time Process
S002 2007-01-11 Real-time Process
S001 2006-06-08 135 Review Track For 30-day Notice

NIH GUDID Devices

Device IDPMASupp
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